The Effects of Cannabidiol and ∆-9-THC in Humans
This study is currently recruiting participants.
Verified March 2013 by Yale University
Sponsor:
Yale University
Information provided by (Responsible Party):
Mohini Ranganathan, Yale University
ClinicalTrials.gov Identifier:
NCT01180374
First received: August 10, 2010
Last updated: March 22, 2013
Last verified: March 2013
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Purpose
Cannabis is the most commonly used illicit substance in the US and herbal cannabis consists of a number of cannabinoids including Δ-9 THC and CBD. This study will characterize the interactive effects of the two major components of cannabis i.e. Δ-9-THC and CBD.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Cannabidiol Drug: Delta-9-THC Drug: Placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Cannabidiol Modulation of ∆-9-THC's Psychotomimetic Effects in Healthy Humans |
Further study details as provided by Yale University:
Primary Outcome Measures:
- Behavioral Measures [ Time Frame: Baseline, +15, +80, +240 ] [ Designated as safety issue: No ]Subjective effects, perceptual alterations, and cognitive effects will be assessed using visual analog scales, Positive and Negative Symptom Subscale (PANSS), Clinician Administered Dissociative States Scale (CADSS), Psychotomimetic States Inventory (PSI) and a neuro cognitive battery.
| Estimated Enrollment: | 36 |
| Study Start Date: | June 2010 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active Canabidiol and Active Delta-9-THC |
Drug: Cannabidiol
Active Cannabidiol 5mg.
Drug: Delta-9-THC
Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or "joint".
|
| Placebo Comparator: Placebo and Active Delta-9-THC |
Drug: Delta-9-THC
Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or "joint".
Drug: Placebo
Placebo (about a quarter spoon of alcohol with no CBD).
|
| Experimental: Active Cannabidiol and Placebo |
Drug: Cannabidiol
Active Cannabidiol 5mg.
Drug: Placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
|
| Placebo Comparator: Placebo and Placebo |
Drug: Placebo
Placebo (about a quarter spoon of alcohol with no CBD).
Drug: Placebo
Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
|
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Exposed to Cannabis at least once in lifetime
Exclusion Criteria:
- Cannabis Naive
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180374
Contacts
| Contact: Brynn Huguenel, B.A. | 203-932-5711 ext 4650 | brynn.huguenel@yale.edu |
Locations
| United States, Connecticut | |
| VA Connecticut Healthcare System | Recruiting |
| West Haven, Connecticut, United States, 06516 | |
| Contact: Brynn Huguenel, B.A. 203-932-5711 ext 4650 brynn.huguenel@yale.edu | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Mohini Ranganathan, M.D | Yale University Medical School |
More Information
No publications provided
| Responsible Party: | Mohini Ranganathan, Principal Investigator, Yale University |
| ClinicalTrials.gov Identifier: | NCT01180374 History of Changes |
| Other Study ID Numbers: | 1001006240 |
| Study First Received: | August 10, 2010 |
| Last Updated: | March 22, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Yale University:
|
Cannabis Marijuana Cannabidiol |
CBD THC Psychotic Disorders |
Additional relevant MeSH terms:
|
Tetrahydrocannabinol Hallucinogens Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses |
Psychotropic Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013